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At Intuitive, we are seeking a highly skilled Cleanroom Engineer to join our team. As a Cleanroom Engineer, you will be responsible for ensuring the site's Controlled Environment Rooms (CERs) meet regulatory standards and industry best practices.
Key Responsibilities:
- Regulatory Compliance: Manage and continuously improve existing CER operating procedures and controls to ensure compliance with regulatory standards.
- CER Management: Review, manage, and approve changes or modifications to CERs, including the addition of new processes, equipment, or materials.
- Training and Development: Develop, promote, and implement CER operations training programs and initiatives to ensure colleagues and new hires are equipped with the necessary skills and knowledge.
- Quality Assurance: Manage and review environmental and product nonconformance issues to ensure quality standards are met.
- Process Improvement: Challenge and continuously improve CER cleaning methods, frequency, and efficacy to optimize operations.
- Supplier Management: Document requirements and assist in evaluating new CER service suppliers for capability, infrastructure, and compliance.
- Subject Matter Expert: Participate in the development of new CER specifications, commissioning, and validation for new construction, and serve as a subject matter expert for cleanroom operations during quality and regulatory audits.
